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ABDA: The fact sheet formulation drugs with cannabis has been updated and is available for download.

ABDA:  The fact sheet formulation drugs with cannabis has been updated and is available for download.


Updated: June 21, 2018 What is cannabis?

»Cannabis is the scientific name of the genus hemp and is colloquially used for plant parts and products, in particular for marijuana (flowers of the female plant) and hashish (resin). Medicinal use of cannabis

»The data on the medicinal use of cannabis in various indications is inconsistent.1 There is good evidence for the therapeutic benefits of cannabis and cannabinoids in chronic neuropathic or cancer-related pain and spasticity due to multiple sclerosis. There are moderate evidences of efficacy against nausea and vomiting as a result of chemotherapy. In contrast, little or no evidence has been found that cannabis and cannabinoids help with chronic rheumatic pain, improve the appetite of patients with HIV and slow their weight loss, relieve symptoms of Tourette’s and anxiety disorders, psychosis or post-traumatic stress syndrome.

»On March 10, 2017, a law on the medical use of cannabis came into force. (“Act amending narcotics and other regulations”) 2> Physicians may prescribe cannabis to their patients upon prior approval by the health insurer, and pharmacies may manufacture appropriate prescription medicines. For medical use, cannabis flowers can be inhaled after being heated in special evaporators or drunk as an aqueous decoction (“tea”). > These prescription medicines containing cannabis are reimbursed by health insurances. The current Pharmaceuticals Price Regulation (AMPreisV) is applicable to the pricing of medicinal products manufactured from cannabis. Patients are required to make a co-payment of 10 percent of the drug price, but no more than 10 euros per drug.3 1 http://jama.jamanetwork.com/article.aspx?ar 2 »In 2017, pharmacies will have to pay the statutory health insurance companies around 44,000 units of cannabis prescription drugs delivered4. Statements about the number of patients or the amount are not possible. »Availability: The Federal Government had no information available in June 2018 that the delivery difficulties for cannabis flowers that occurred in the summer of 2017 persisted5. If in individual cases in a pharmacy a certain sort of cannabis flowers are not in stock, this could be the case in another pharmacy. There is also a potential for physicians to prescribe alternative cannabis-based prescription or finished medicinal products. Pharmaceutical Evaluation of Cannabis

»In total, more than 400 different ingredients have been detected in cannabis. Main ingredients are the so-called cannabinoids. Important ingredients for medical use are delta-9-tetrahydrocannabinol (Δ9-THC, also called dronabinol) and cannabidiol (CBD) in the form of largely pharmacologically inactive precursors (“THC-A” or “CBD-A”). considered. »In cannabis plants and their extracts – as with all natural products – the concentration of the various ingredients varies. There are several varieties of cannabis flowers available that contain different concentrations of the precursors of the main ingredients Δ9-THC and CBD. DAC / NRF Monographs and Formulation Regulations »The German Medicines Codex (DAC) and the New Formulation Form (NRF) are the responsibility of the DAC / NRF Commission. The publisher is the ABDA – Bundesvereinigung Deutscher Apothekerverband e. V. It appoints the independent expert DAC / NRF Commission. > DAC monographs contain information that aggregates the pharmaceutical knowledge of the active substance described. In DAC monographs u. a. Test method for identity, purity and content as well as storage and application instructions described. > NRF recipe prescriptions contain information on the preparation but also on the use of prescription drugs.

»For Dronabinol, there has been a DAC monograph since 2001 as well as the standardized NRF 4 ABDA press release dated 8 March 2018, https://tinyurl.com/y7tonsqe 5 Federal Government Response to Small Request, June 14, 2018 http: / /dip21.bundestag.de/dip21/btd/19/027/1902753.pdf 3 Formulation instructions for capsules and drops for oral use. In addition, in March 2017, the NRF formulation requirement for a solution for inhalation was pre-published.

»In 2015, a DAC monograph and an NRF prescription protocol were published for cannabidiol as the starting material and for cannabidiol solution as an oral preparation. Cannabidiol is not an anesthetic, but since 2016 de